FDA Inspection
Professional Compounding Centers of America dba PCCAProfessional Compounding Centers of America dba PCCA – FDA Inspection, Feb 23, 2017
Record Details
This FDA Inspection record concerns Professional Compounding Centers of America dba PCCA, with an inspection on February 23, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 23, 2017
- Product Type
- Drugs
View Company Profile
ID · 2eb4a9bc-2dd6-4e32-b142-63d84973cb49
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009088
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Professional Compounding Centers of America dba PCCA
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 21, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 29, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 4, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 14, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 11, 2009 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Professional Compounding Centers of America dba PCCA
- FDA Inspection 1203293 - 2023-04-21
- FDA Inspection 1110247 - 2019-10-29
- FDA Inspection 1088936 - 2019-03-04
- FDA Inspection 772317 - 2012-03-14
- FDA Inspection 584122 - 2009-06-11
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.